Orthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk
Orthofix is recalling Firebird Spinal Fixation System rod connectors because a sub-component may crack during tightening.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a spinal fixation device, which meets the rubric criteria for a Severe rating.
Plain-English summary
Orthofix, Inc. is recalling the Firebird Spinal Fixation System, specifically the Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). The recall involves 565 total units, consisting of 287 Parallel Rod Connectors and 278 Axial Rod Connectors.
The recall is due to a possibility that the Set Screw (p/n 90-2923) sub-component may crack during final tightening. Orthofix received six customer complaints related to set screw cracking between November 15, 2010, and December 2012.
The affected products were distributed worldwide, including the United States (nationwide and Puerto Rico), Australia, Lebanon, Germany, Spain, Sweden, and Israel. All lot numbers are affected. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a…
- Manufacturer
- Orthofix, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Numbers: 52-6800 & 52-6700
- All Lot Numbers
Distribution
Related recalls
Same manufacturer · Orthofix, Inc
See all →- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- ModerateOrthofix Firebird Spinal Fixation System Recalled for Mislabeling
FDA (Devices) · 2015-06-17
- HighOrthofix Firebird NXG Spinal Fixation Set Screw Driver Recalled
FDA (Devices) · 2016-06-08
- HighOrthofix Firebird Spinal Fixation System Torque Limiting Handle Recall
FDA (Devices) · 2016-02-17
- HighOrthofix Firebird Modular Screw Driver Recalled for Collet Malfunction
FDA (Devices) · 2014-02-05
- HighOrthofix Recalls Connector System Set Screws Due to Size Discrepancies
FDA (Devices) · 2018-04-18
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13